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sumbuysumsell[quote]Food for thought. There's power in staying quiet.
[/quote]
YUP, (for example) The FDA has been completely wrong on the whole Amyloid Plaque thing for at least 100 years now???HUH...wonder why??? SILENCE WORKS...(along w/BP and who knows about the herd??). IMO, Massive $$$$ is part of the answer.
Anyone see/understand how multiple regulatory body approvals works/benefits/slows/accelerates the open market sales picture for A2-73 (for example?). Since it seems clear that FDA would have to be suicidal (due to multiple time internally established tangles and conflicts) to lead the parade for AVXL CNS treatment approvals. Then, which national-body or reginal interests stands to benefit the most by approval use-scripting-sales for their populations of clinical users?
A. Who will be first? When? Why ?
B. How does FDA unscrew itself from Amyloid thesis CNS disease past w/a straight face and move on? (CAN THEY) (THEN WHAT?)
What other top management regulatory issues are in the way of moving FWD right now???
What will be AVXL-Dr.M. and staff's next move to drive the above issues??
OK, let's not let some rough water screw up all the good-great work done by the AVXL operations/Mgmt. team. Very rough SP day today after a strong effort to get here , We have been through worse than this.
CARRY ON.
We credit Dr.M. that this is not just a conventional card game of wits. AD is about people (family members) getting treatment or not for a disease that will kill them. The sooner a few liars-criminals-get executed to demonstrate seriousness ,, the better.
Thank you powerwalker...thank you...WGT...
I like that Steve Forbes identifies himself as "Forbes Staff."
I think he and/or his foundation has bought a good number of shares in AVXL, SAVA and ANVS after his team did the research for this article.
So Powerwalker, then looks like that old expression ..."You are NOT CRAZY, they REALLY ARE AFTER YOU...!!!....comes to mind.
Steve Forbes Forbes Staff
“With all thy getting, get understanding."
Feb 7, 2023,06:00am EST
Why is there no cure for Alzheimer’s—or why aren’t there medications that can at least substantially slow or meaningfully ameliorate the disease? It afflicts more than 6 million Americans, with that number on its way to doubling within a generation.
Alzheimer’s is a hideous ailment for both the sufferers and their families and friends. Yet even though the disease was first diagnosed by psychiatrist Alois Alzheimer in the early 1900s, progress in fighting it has been almost nonexistent. What’s scandalous is that for decades research has been almost entirely focused on the wrong hypothesis.
Dr. Alzheimer noted in the autopsy of the patient’s brain with the disease that came to bear his name that it was densely loaded with two proteins called plaques and tangles. Unfortunately, the dominant thesis in research on the disease has been that attacking plaques, and to a lesser extent tangles, would cure the ailment and enable the brain to regain its health.
Alzheimer himself warned about focusing too much on plaques and tangles as causes. In fact, some sufferers of Alzheimer’s have proved to have had little in the way of plaques, while others who had plaques didn’t have the disease.
Nonetheless, despite constant failures—some 20 drugs have been developed that ended up as flops—and the expenditure of tens of billions of dollars, the main thrust of research remains focused on fighting plaques.
The obsession with this dead-end approach has been fanatical, almost cultlike. Researchers who want to pursue more promising avenues have faced serious obstacles. Rarely has chronic failure resisted correction on something so important.
You may have heard of a new drug called lecanemab, which is being heralded as a fantastic breakthrough. But lecanemab is based on the wrongheaded plaques hypothesis. As noted health policy journalist Joanne Silberner sadly points out, “At best, lecanemab might slightly slow a patient’s inevitable decline for a few months.”
This research scandal shows the danger of groupthink, particularly when there’s a powerful government agency such as the National Institutes of Health putting the kibosh on grants for nonconsensus projects.
A classic case of similar groupthink involved the cause of stomach ulcers. The once-prevailing view was that stress and lifestyle were the cause, and drugs and regimens were developed on that belief.
This dogma was challenged by two Australian physicians, Robin Warren and Barry Marshall. They posited that the villain was bacteria and that antibiotics were the answer for a permanent cure. When not ignored, their discoveries were derided. Only after many years and constant, sometimes unorthodox advocacy, especially by Dr. Marshall, did the medical world accept their truths. The two were eventually awarded the Nobel Prize in Medicine.
In the case of Alzheimer’s, the rigid research mentality has begun to soften, but only slightly. To attack this deadly rigidity, Congress should hold hearings on the subject, starting with the leaders at the National Institutes of Health.
Steve Forbes is Chairman and Editor-in-Chief of Forbes Media.
https://www.forbes.com/sites/steveforbes/2023/02/07/the-scandal-of-alzheimers/?sh=34284da66a41&bsft_aaid=a4679c91-eb03-4591-93c2-79b7f25f9cbd&bsft_eid=15374f1b-1165-4402-b482-cdabfc723dde&utm_source=blueshift&bsft_clkid=39bb3ca5-f842-4f84-a918-78a3d2514c58&bsft_uid=8a4ab049-cac4-4359-ae99-bc1e70d3b870&bsft_mid=6fae9050-ef21-411e-9d1c-4e5f7b0849ca&bsft_utid=8a4ab049-cac4-4359-ae99-bc1e70d3b870-DRPROOF&bsft_mime_type=html&bsft_ek=2023-02-07T21%3A30%3A36Z&bsft_lx=20&bsft_tv=4&pk=ce01a6586b8394cd219d9d4151b05359&utm_campaign=DAP_ISSUE_02.07.23&utm_medium=email&vid2=9cd562d8abdeeda86039a61cc7e5dc63e585d49a727e626584f7ccd81870dffd80f6507937c7784a56ba72af38c88171
Bullish
BULLISH
Steve Forbes Forbes Staff
“With all thy getting, get understanding."
Twice Worthy
especially, with our desperate FDA approving a new Alzheimers drug causing that causes brains to bleed and patients to die.
Agree, gbrown...We'll see , but I do expect we(AVXL) will start to get a lot more attention and respect as our results begin to speak and sink in...WW. IMO, Dr.M. is also describing a process for moving fwd.
Working further upstream is a massive strategic change for all/most of BP. IMO, some will "GET IT" , others NOT. IMO, all we need is ONE GOOD WIN with this new upstream focus and OUR MOA will sink in.
It's a LONG story but we are on the point leading a change (w/some friends soon to join, IMO) while the rest are going to be watching w/the Amyloid (FDA) Thesis crowd as AVXL (etal w/friends) results demonstrate the way out of the woods. BUT, the HERD has to WANT TO listen first. That is what we are seeing now, fingers crossed.
Dr.M.
We believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled Phase 2b/3 Alzheimer disease trial, which data suggests that ANAVEX 2-73 blarcamesine, an orally available small molecule activator of the upstream sigma-1 receptor is pivotal to restoring neural cell homeostasis and promoting neuroplasticity and might be at the forefront of biomarker guided pathway based targeted precision medicine drug development.
gbrown6332
As it stands, and I realize it was an earnings call, the call was short on information, dry as dirt and provided no anticipation for when another update might be expected.
Anavex Life Sciences to Announce Fiscal 2023 First Quarter Financial Results on Tuesday February 7, 2023
jonjones325
Missling is setting up for growth and expansion and has been for some time. He is data driven in all that he does and this is no different. ).
The regulatory hire, biostatistician, IR, Grimmer, etc. A great leader surrounds himself with great leaders.
georgejji
The trial enrolled 272 patients who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging.
Kentucky 123
AVXL has been on the back page for a long time. TGD has indicated the he needs to get the affected community involved along with the general population. The new hire is a good start. We first need to get an undeniable success. Then start waving the arms.
hnhbadger1
EU/ Aus approval for anything!
OK.....FAST FWD,,,,. It is now 7:00 AM EST 2/7/23...you turn on your Computer and go to your AVXL info-mail site...What (if ANY ) AVXL surprise news do you EXPECT to see? What do you WANT to see?
Are AVXL planning to implement the expected TRIFECTA ? I. RSD multi national trials w/synchronized-planned (Verification and Validation programs). II Followed by summarized PDD - OLE results. III. Final publication of TLR AD summary report to include Peer reviewed publication. All w/in Q1-CY-23 ? Cards are on the table, IMO.
I. RSD . https://finance.yahoo.com/news/anavex-life-sciences-announces-exceeding-120000524.html
II. PDD-OLE report
III. AD-TLR - Followed by Peer Reviewed Publication
McM...you got it right OK...all we need is a few RWD-RWE examples w/undeniable evidence...when people start to see-soak al little -and catch their breath , then...BBBBBOOOOOMMM...you'll know when it happens...
Great post-another learning moment. THX.
do the right thing
Why does the company keep doing this? At this point it would be better to just not announce any expected timelines. Just say results pending or something like that. I can't recall them ever hitting on one of these timelines. q2 2024 it is... Another year gone
McM
Everyone.
They will titrate up to max wax..
Once they know..
What we should be thinking about is
How do we increase our S1r signature within our bodies?
https://finance.yahoo.com/news/anavex-life-sciences-announces-exceeding-120000524.html
Lets each take a few and reflect-pray for the ongoing success of these AVXL CNS treatments and be particularly thankful for the hoped for efficacy of rare disease treatments for these dear little kids/families. Hugs all around and for good news to follow. Bless them all.
Plexeec
Very strong close to today's trading--buyers pushing up SP--looks like sumthin cook'n !!!
Falconer
What can I explain to my wife?
Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy.
I can say w/authority (been there-done) that this method recruiting-starting is how most of the "Silicon Valley-START UP-SPIN OFF's ", were created...in the 70's. Good - verity best-where competent people meet, pay attention to technology-respecting each others progress and payback over a period of time and POOF...They Move on.
It is a very tight-closely knit way to get (options) wealthy/identified fast and to pick who you want to work with. Typically, the very best high tech-leaders know and trust each other. I would predict that Anavex will soon not have a problems attracting the very best talent, WW.
Nidan
FDA is due for a major axx kicking...and (hopefully), AVXL will be a big part of that WW effort.
We have all heard the expression... "Too Big To Fail"...The current version of FDA is an example of how that (OLD RULE) is JUST WRONG. FDA does a lot of things well, defining basic processes is an example of what they have done and continue to do well.
Having an internal -self correcting loop (an internal review process) is something they will not ever do well b/c it is currently fundamentally a politically based system. The overwhelming amounts of $$$ on the table for just about every decision they make is a massive thumb on the scale and it shows...BIGLY.
I would not want to be a statistical leader trying to deal with the balance of truth vs $$$$. Heading to AVXL is a wise move.
JonJ325
How do you even poach a guy like Kun Jin?
Staedy_T...
Grasp the concept. The FDA does not tell industry what to research. At best the NIH provides funding for specific research areas. Industry decides where they want to spend research money on.
Wow, just imagine what will be written when AVXL delivers a CNS treatment that is BOTH...SAFE AND EFFECTIVE.
going long...
Adriane Fugh-Berman is a professor in the departments of pharmacology and physiology and in the department of family medicine at Georgetown University Medical Center, where she’s also the director of PharmedOut, a research and education project that promotes evidence-based prescribing.
She wrote:
A treatment that improves Alzheimer’s disease would be a great advance, but Leqembi (lecanemab), which recently received accelerated approval from the FDA, is not that drug.
Yes, lecanemab slows decline to an extent detectable on a test, but not to an extent that a relative or caretaker would notice. This drug doesn’t actually make anything better. It just slows the rate that someone goes downhill over 18 months — by less than half a point on an 18-point scale. And we don’t know whether things get better or worse after that.
...
The Alzheimer’s Association, which takes money from Biogen, called the approval of Aduhelm a “victory for people living with Alzheimer’s and their families.” Of Leqembi, the Association claims that this treatment addresses “the underlying biology of Alzheimer’s and changes the course of the disease in a meaningful way for people in the early stage” and, again without evidence, that, “Individuals will have more time to participate in daily life and live independently.”
...
The Alzheimer’s Association, predictably, has been pressuring the Centers for Medicare and Medicaid Services (CMS) to have Medicare cover Leqembi. There’s no reason to think that Leqembi will be marketed any more responsibly than Aduhelm. It’s up to physicians, patients and CMS to reject an expensive drug that improves no symptoms and puts users at risk of fatal bleeds.
If the FDA had spent the last 100+ years developing an effective accelerated CNS test method then we would have a solution for multiple CNS diseases today . Until that is done, we are going nowhere. Not a tough concept . For example, the AD amyloid thesis would been shat-canned decades ago, for example.
Nice work PW, as you point out 115 years is a long time for any science to be continuously wrong. That fact alone is mind blowing, IMO.
On Nov. 3, 1906, German psychiatrist Alois Alzheimer presented the clinical features of Auguste Deter — the first patient diagnosed with the disease — together with the neuropathological features that included brain shrinkage and the presence of a protein found between brain cells (amyloid plaques) and the Tau protein identified within the brain cell.
Today, more than 115 years later, Alzheimer’s is a major health problem globally, and the amyloid hypothesis — that amyloid accumulation causes dementia — dominates the research community. This hypothesis has guided drug development, and pharmaceutical companies saw a huge opportunity. Lecanemab is the first drug that lowers brain amyloid levels and ostensibly slows progression. That being said, that proof of principle is tenuous in this case. The Lancet editorial appropriately states, “Whether lecanemab is the game changer that some have suggested remains to be seen.”
[Published in Chicago Tribune 1/27/2023]
The U.S. Food and Drug Administration recently approved a new drug for the treatment of Alzheimer’s disease. AP 2020
By Anand Kumar
May God Bless Rosie. She is on a path we each must pass at some point. Seems like she has had an opportunity to do a KIND OF..RESET , thanks to AVXL...let's hope it continues to go well for her and her family.
Life really is too short, even for those of us who live a normal/average at least, time ...but it is still far to short a time. My vote is for a shrinking WW population composed of those pay attention and do care to (at least try) act to make a difference.
The older we get, the more preciously our time is valued.
pete
You don't have to go far to find them.
pete...thanks and agree...
Reminds me of Dr. Peter Senge and his work with systems thinking. He is a brilliant guy and a BIG thinker. (ref; Dr. Senge's book, "The Fifth Discipline")
Dr. Senge points to the three levels of knowledge that we all live with.
a. Those things we know , and we know we know them.
b. Those things we do not know, and we know we do not know them.
c. Those things we do not know, and we do not know we do not know them.
I claim that new learning must happen at the interface to the second stage of phase b. . IMO, AVXL staff are now pushing the AD CNS disease knowledge envelope at the level b. science interface. We also must have a lot of people who cannot wait to get a peek at level c. IMO, that is why some are coming aboard AVXL as we speak, while they could go anywhere they want, they must chase level c. (MORE FUN W/DOTS)
My biggest concerns remain in the scale and scope of the concurrent WW CNS diseases trial effort. Multiple-different regulatory country/consideration(s). Multiple CNS indications, w/multiple agencies WW and CRO interfaces. Has anything even close to this complexity ever been attempted...think not.
The good news is, AVXL are rewriting the WW AI-precision med "HOW TO MANUALS" while all the BP's stand around w/open mouths while Dr.M. and team are eating their lunches. (BTW-they-(some) are beginning to see that-IMO.)
The AVXL upstream S1R CNS thesis is taking shape while all others remain in their same ole serial driven hopeless -bottomless pit. WGT. AVXL has already won and the BP ROW does not even know it. Just stand by as they begin to experience their respective AAAAAHHHHAAAA RWE (OH SHAT) respective MOMENTS. It is all beginning to show ....
Why is this not criminal risk to an innocent patient?
STORY AT-A-GLANCE
The U.S. Food and Drug Administration (FDA) granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi)
The drug, a monoclonal antibody, binds to amyloid beta in the brain
The most common reactions included amyloid-related imaging abnormalities, or ARIA, which involves swelling and bleeding in the brain that can be life-threatening. During the trial, ARIA occurred more often in people with the APOE4 gene, which is considered to be the strongest risk factor for Alzheimer’s disease
Amyloid beta may be a symptom of Alzheimer’s — not the cause — and could even have a protective role in the disease process
This means drugs that work by reducing amyloid beta may be missing the problem entirely, putting patients at risk of serious adverse events for little to no benefit
Mercola - FDA Accelerated Approval for Risky Lecanemab, reliance on drugs to reduce amyloid beta may be misguided.
FDA Approves Risky FDA Approves Risky Lecanemab
What happens when the FDA is finally forced to admit that the amyloid Plaque AD causal thesis has not been proven (after 30+ years)? If everyone has to do a mid air restart (or die) ...then what??
We recognize the discipline, process structures and process skills required to manage a regulatory body must continue...but...where will they begin when the AD causal thesis has been finally-totally buried? Will the future be AI-science driven using precision medicine disciplines or will current BP practices keep continue.